阿德福韦酯和拉米夫定治疗活动性肝炎肝硬化的临床比较

A clinical study of adefovir dipivoxil and lamivudine in the treatment of cirrhosis resulting from active chronic hepatitis

目的观察并比较阿德福韦酯和拉米夫定治疗活动性肝炎肝硬化的疗效和不良反应。方法将52例活动性肝炎肝硬化患者,随机分为2组:阿德福韦酯组28例,给予阿德福韦酯10 mg/d;拉米夫定组24例,给予拉米夫定100 mg/d,疗程均为48周。均给予常规护肝及支持、对症治疗。观察并比较2组患者的肝功能、HBeAg、HBV DNA、肝纤维化标志物(Ⅲ型前胶原、层粘连蛋白、透明质酸)、肾功能的变化以及药物不良反应。结果2组患者肝功能各项指标的复常率、血清HBV DNA转阴率、HBeAg/抗HBe转换率均随着疗程的延长而增高,但2组比较,差异无统计学意义(P>0.05)。治疗至48周时拉米夫定组有2例发生酪氨酸-蛋氨酸-天冬氨酸-天冬氨酸(YMDD)变异,变异率2/24(8.3%),阿德福韦酯组无病毒变异发生。2组患者血清肝纤维化标志物治疗至24周时明显下降,且随着疗程的延长进一步降低,两组比较差异无统计学意义(P>0.05)。结论阿德福韦酯与拉米夫定在抗病毒治疗方面的疗效和安全性相似,但病毒耐药突变率较拉米夫定低。

Objective To evaluate the efficacy and adverse reactions of adefovir dipivoxil （ADV） and lamivudine （LMV） regimens for cirrhosis resulting from active chronic hepatitis. Methods 52 patients were randomly divided into two groups： ADV group, 28 patients treated with 10 mg of ADV daily; and LMV group, 24 patients treated with 100 mg of LMV daily. The course of treatment lasted 48 weeks in both groups, coupled with routine support of the hepatic functions and symptomatic treatment, so as to observe their hepatic functions were including serum levels of alanine aminotransferase （ALT）, aspartate aminotransferase （AST）, Alb, TBil, HBeAg, HBV DNA, hepatic fibrosis indicators PC Ⅲ, LN and HA, and renal functions, adverse reactions of the drugs. Results The ratios of recovery for liver functions and the sero - conversion rate of HBV DNA, HBeAg/Anti - HBe increased with prolonged course of treatment ; though, the differences between the two groups were not statistically significant （ P 〉 0.05 ）. Two patients treated with lamivudine suffered from YMDD variation in the 48^th week; the ratio of variation was 8.3% , while no YMDD variation was found in the ADV group. The levels of serum hepatic fibrosis indicators decreased markedly in both groups in the 24＇h week, with prolonged course of treatment. There were no significant statistical differences between the two groups （ P 〉 O. 05 ）. Conelusion Adefovir dipivoxil and lamivudine have similar efficacy and security in the antiviral treatment, but the ratio of virus -resistant mutation was lower in adefovir dipivoxil group.